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GUDID v2.3

The FDA have announced their plan for the latest version of GUDID, version 2.3 will see some specific data made available to the public. The latest version will be available from May 2018 and the FDA will make the data publically available from June 2018.

The FDA have stated

The FDA plans to make public the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI) record via AccessGUDID and OpenFDA. The premarket numbers provide an essential link to information about device safety and effectiveness; making them public as part of the GUDID DI record information is crucial to achieving the public health benefits of UDI.

FDA GUDID Enhancements and Fixes

Following these changes the FDA goes on to strongly encourage labellers to review their confidentiality agreements, if they wish they can then assign confidentiality designations to proprietary names for existing listings.

For support with your FDA device registrations, FDA UDI compliancy and regulatory tracking reach out to our expert team via +44 1785 825653 or email [email protected]

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